Nicotine Patch Pretreatment for Smoking Cessation in PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00625131
First received: February 19, 2008
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

This study seeks to evaluate the relationship between PTSD, abstinence, and factors associated with relapse in the context of a randomized, clinical smoking cessation trial.


Condition Intervention Phase
Stress Disorders, Posttraumatic
Tobacco Use Disorder
Drug: Nicotine
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
Drug: Bupropion SR
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Nicotine Patch Pre-treatment for Smoking Cessation in PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Smoking abstinence, self-reported [ Time Frame: Weekly, visits 6 through end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carbon monoxide monitoring [ Time Frame: Weekly, all study visits ] [ Designated as safety issue: No ]
  • Smoking craving, PTSD symptoms, and mood [ Time Frame: Daily between visits 2-12 ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: May 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Transdermal nicotine patch
Drug: Nicotine
Delivered through transdermal nicotine patch
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
Manualized protocol for CBT in smoking cessation
Other Name: CBT
Drug: Bupropion SR
Antidepressant
Other Name: Zyban, Wellbutrin
Placebo Comparator: Arm 2
Transdermal placebo patch
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
Manualized protocol for CBT in smoking cessation
Other Name: CBT
Drug: Bupropion SR
Antidepressant
Other Name: Zyban, Wellbutrin

Detailed Description:

Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for three weeks before a target quit-smoking date. All participants to will receive bupropion beginning 1 week prior to their quit day, given that they are medically eligible to be prescribed bupropion. All participants will receive a two session brief cognitive-behavioral therapy (CBT) session and will begin standard nicotine replacement therapy (NRT) on their quit day. PTSD symptoms, mood, and smoking craving will be carefully evaluated throughout the study using electronic diary assessments on personal digital assistants (PDA). Specifically, participants will carefully monitor their symptoms, mood, craving, and use of cigarettes using electronic diaries for one week prior to the pre-cessation period, during the 3-week pre-cessation treatment period, and 6 weeks post quit date. Since no previous study has examined factors associated with smoking abstinence following treatment among PTSD smokers10, predictors of treatment response will be examined. The study is designed to address the following items:

Specific Aim 1: To evaluate whether supplemental nicotine administration (i.e., pre-cessation treatment with nicotine patch and bupropion) will result in improved quit rates among smokers with PTSD.

Hypothesis 1.1 Supplemental nicotine administration during the pre-cessation period will result in improved quit rates in the first quit week over the placebo patch condition.

Specific Aim 2: To utilize electronic diary assessment of PTSD symptoms, mood, smoking craving, and smoking during baseline, pretreatment, and quit periods to evaluate potential mechanisms of how pretreatment with the nicotine patch may increase abstinence rates.

Hypothesis 2.1 Supplemental nicotine administration will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition.

Hypothesis 2.2 Supplemental nicotine administration will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior, i.e., symptom relief from ad lib smoking a cigarette will be reduced during supplemental nicotine administration as compared to the placebo patch condition.

Specific Aim 3: To investigate potential predictors of smoking abstinence and relapse associated with individual differences in affective style including anxiety sensitivity, measures of distress tolerance, and self-efficacy.

Hypothesis 3.1 Increased anxiety sensitivity will be predictive of shorter abstinence from smoking.

Hypothesis 3.2 Decreased distress tolerance will be predictive of shorter abstinence.

Hypothesis 3.3 Lower self-efficacy for smoking abstinence will be predictive of shorter abstinence.

Hypothesis 3.4 Increased PTSD symptoms severity and negative affect following the quit date will be associated with shorter abstinence.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smokers who smoke 10 or more cigarettes per day in the past year;
  • 18-80 years old;
  • English speakers;
  • medically stable;
  • stable on current medication regimen

Exclusion Criteria:

  • Pregnant women excluded;
  • participants with organic mental disorder, schizophrenia, bipolar disorder, lifetime but not current PTSD, current substance abuse or dependence;
  • medical conditions contraindicated with nicotine replacement therapy;
  • use other forms of nicotine (cigars, nicotine gum, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625131

Locations
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Jean C. Beckham, PhD VA Medical Center, Durham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00625131     History of Changes
Other Study ID Numbers: NEUA-007-07F
Study First Received: February 19, 2008
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Stress Disorders, Posttraumatic
Tobacco Use Disorder

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Tobacco Use Disorder
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014